What is Novum?

Novum is a Contract Research Organization (CRO) that provides research services to the worldwide pharmaceutical industry. For over 40 years, Novum has been considered one of the world’s leaders in the conduct of clinical trials. Novum has completed over 3,000 studies for more than 300 pharmaceutical companies.

What types of studies do you conduct?

We conduct three types of studies: Outpatient, Topical/Skin and PK-Bioequivalence. These studies can be as brief as two days or may last as long as three to six weeks. Some may require overnight stays and blood draws and others will not.

What kinds of drugs do you test?

We test newly developed medications as well as new formulations and generic equivalents of medications already on the market. These can either be prescription or over-the-counter medications and could include tablets, capsules, nasal sprays, patches, skin creams, etc.

What is the procedure for participating in a study?

After you’ve inquired by phone or through the website about being a study participant, you will be added to our participant database. A Novum recruiter will then contact you and ask you a few personal and general health questions. If you meet the criteria for one of our clinical studies, we will schedule your visit to the clinic for a screening appointment.Read More »

Do I have to have the particular condition that the drug is used to treat in order to participate in a study?

Will I be paid?

Yes, our participants will be paid a study fee based upon the length and complexity of the study. If the study requires several visits you will be given a progress payment at each visit. The bulk of the money will be paid by check at the end of the study.

Do study participants stay overnight?

Most of our studies involve an overnight stay. Some stays require only one night with us. Frequently, studies involve a number of overnight stays that extend over two or more visits. For example, you would arrive on a Friday evening and would leave on a Sunday morning for a total of two weekends.

Will meals be provided during my stay?

What can I do during free time?

You will have lots of time to do many different activities. Clinics have an assortment of items for you to enjoy, including televisions, board games, video game players and computers. You can catch up on your reading, do homework or just play cards. Feel free to bring your personal tablet, laptop, smartphone, etc.

Can I leave the facility after checking in?

If you want to complete the study, once you are checked into a study you cannot leave to go to work or perform other outside activities. You can, of course, leave at any time but you will only be compensated for the time of the study you complete.

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What is the procedure for participating in a study?

After you’ve inquired by phone or through the website about being a study participant, you will be added to our participant database. A Novum recruiter will then contact you and ask you a few personal and general health questions. If you meet the criteria for one of our clinical studies, we will schedule your visit to the clinic for a screening appointment.

The screening visit will include meeting with a medical staff member who will explain to you the details about the clinical research study and any known side effects associated with the drug being tested. After you have had time to read through the study information and all of your questions have been answered, we will ask you to sign the Informed Consent Form for the study.

A physical exam will be conducted at no cost to you to make sure you meet the study requirements. We will be checking:

Height, weight, temperature and blood pressure

Heart trace (electrocardiogram - EKG)

Blood and urine analysis, including a drug screen and pregnancy test

Other tests may be done if required for the study.

All the information you provide during your screening visit will be kept strictly confidential. If any of the screening results require follow-up from a health care provider, a Novum staff member will call you. If you decide to have additional evaluations and/or treatment, these will be at your own expense.

If you qualify for a clinical study after screening, we will contact you to let you know. Remember, your participation in any clinical research study is voluntary and you are free to withdraw at any time.

If you are participating in a study with overnight stays (inpatient study), you must be available to remain in the clinic for the entire period of the study. These studies vary in length. We have medical staff on site to ensure your safety and comfort during your entire stay. All meals, accommodations, entertainment and recreation facilities are provided to you at the clinic. If you are participating in a study that will require you to fast (not eat) for a short period of time during your stay, you will be told during the informed consent process in screening. You must remain in the clinic for the duration of the study and return for all scheduled appointments to complete the study and receive your final payment for participation.

If you are participating in a study without overnight stays (outpatient study), you will have scheduled return appointments based on the study needs. You must meet all scheduled return appointments to complete the study and receive your final payment for participation.

Outpatient Studies

OUTPATIENT: These types of studies typically test transdermal (e.g., patch) products that are applied directly to the skin. Transdermal products may cause skin irritation (e.g., redness, swelling, itching or burning). The patch itself may also cause skin irritation. Skin irritation studies are used to test the degree of irritation caused by these products and are normally conducted on an outpatient basis. Participants in outpatient studies do not stay overnight with Novum. These studies usually last between three to six weeks, and participants come to Novum on prescheduled visit days and times for study assessments. Each scheduled visit usually lasts about one hour and normally does not require blood collections.

Topical/Skin Studies

TOPICAL/SKIN: These types of studies test topical (applied to the skin surface) corticosteroids (e.g., hydrocortisone). Corticosteroid products cause blanching (whitening) of the microvasculature (very small blood vessels) of the skin. This blanching response is thought to be related to the amount of drug entering the skin. Participants in these studies will have test drug products (e.g., lotions, ointments, creams or tapes) applied to their forearms for specific amounts of time and then the products will be removed. The blanching responses will be measured using a device called a chromameter (color measurement) at regular intervals during the study. Participants will usually stay at Novum two overnights during these studies, and they do not normally require any blood collections.

PK-Bioequivalence Studies

PK-BIOEQUIVALENCE: These types of studies typically compare two drug products, for example, a commercially available Brand product (e.g., Tylenol®) and a potential to-be-marketed generic product (e.g., acetaminophen). Pharmacokinetic (PK) studies are usually performed in which each of the drug products is administered in a cross-over design (each participant will receive each drug product separately over the course of the study) to volunteer participants who are in general good health. After receiving a drug product, blood samples are taken at regular intervals and then tested for the drug concentration. For these types of studies, participants will usually stay at Novum on two separate occasions for two overnights on each occasion. Sometimes, there may be return visits required for additional drug concentration blood collections after being released from the clinic.

Form Submitted

Don't forget to refer a friend.

You will receive $100 for each new person you refer who completes a study.

**If you are not able to participate in any of these studies, please give us a call or register so we can contact you about future opportunities**

Privacy Policy

Introduction

Novum Pharmaceutical Research Services, Inc. (Novum) is committed to respecting the privacy of clinical research subjects. Not only does Novum strive to collect, use and disclose personal information in a manner consistent with the laws of the countries in which it does business, but it also has a tradition of upholding the highest ethical standards in its business practices. The Privacy Policy (the "Policy") sets forth the privacy principles that Novum follows with respect to personal information.

The company complies with the U.S.-EU Safe Harbor Framework and the U.S.-Swiss Safe Harbor Framework as set forth by the U.S. Department of Commerce regarding the collection, use, and retention of personal information from European Union member countries and Switzerland. The company has certified that it adheres to the Safe Harbor Privacy Principles of notice, choice, onward transfer, security, data integrity, access, and enforcement. To learn more about the Safe Harbor program, and to view the company’s certification, please visit http://www.export.gov/safeharbor/.

Scope

This Policy applies to all personal information solicited by Novum in any format, including electronic, paper, or verbal including our Web sites www.gonovum.com and www.novumprs.com.

Privacy Principles

Novum participates in the EU Safe Harbor Privacy Framework as set forth by the United States Department of Commerce. As part of our participation in Safe Harbor, we have agreed to participate in the dispute resolution procedures of the American Arbitration Association for disputes relating to our compliance with the Safe Harbor Privacy Framework. If you have any complaints regarding our compliance with Safe Harbor, you should first contact us (as provided below). If contacting us does not resolve your complaint, you may raise your complaint with the American Arbitration Association here, Novum is committed to respecting the privacy of individuals. Novum has enacted the following procedures to review and monitor the use of personal information and to ensure it is used responsibly and that we comply with recognized standards of privacy protection:

1) NOTICE: When personal information is collected from individuals, they will be informed of the purpose for which the information is collected and how the information will be used. The third parties to whom any information may be disclosed will be disclosed to the individual except as described in this privacy policy (see ”Choice”). Notice will be provided in clear and conspicuous language when individuals are first asked to provide personal information.

On our Web sites we collect, name, email, and phone number (gonovum) and name, business, email, phone, and other business information (novumprs) in order to contact you regarding upcoming clinical trial participation (gonovum) or to send you a promotional CD and other business related information (novumprs).

From time to time we post testimonials on our Web sites. We receive permission to post testimonials that include personal information. If you wish to update or delete your testimonial, you can contact us at privacy@novumprs.com.

We will send you strictly service-related announcements on rare occasions when it is necessary to do so. For instance, if our service is temporarily suspended for maintenance, we might send you an email. We will respond to your requests for information as well.

Generally, you may not opt-out of these communications, which are not promotional in nature.

2) CHOICE: We will give individuals the opportunity to choose (opt out) if their personal information will be disclosed to a third party or used for a purpose incompatible with the purpose for which it was originally collected or subsequently authorized by the individual. All promotional emails sent to users will have unsubscribe instructions included in each email. Affirmative or explicit (opt in) choice must be given if the information is to be disclosed to a third party or used for a purpose other than its original purpose or the purpose authorized by the individual. However, we do not currently collect Sensitive Personal Information from users of our Web site. We may however, in limited circumstances, share personal information with government authorities or others as required to protect the interests of the Novum or others, as necessary in connection with the sale or transfer of all or a portion of the business, or as required by applicable law, subpoena, or court order.

3) DATA INTEGRITY: Novum will use personal information in ways that are compatible with the purpose for which the data was collected. Novum will take reasonable steps to ensure that personal information is relevant to its intended use, accurate, complete and current.

4) TRANSFER TO AGENTS: Novum will obtain assurances from its agents (service providers) such as shipping agents to ship CDs that they will safeguard personal information consistent with this Policy and that they will not use your personal information for their own promotional purposes.

5) ACCESS AND CORRECTION:: Novum will take reasonable steps to permit individuals to correct, amend, or delete information that is demonstrated to be inaccurate or incomplete except where the burden or expense of providing access would be disproportionate to the risks to the individual's privacy or where the rights of persons other than the individual would be violated. You may contact us at privacy@novumprs.com to correct, amend, or delete information as described above. We will respond to any request for access within 30 days.

6) RETENTION: Novum will retain your information for as long as your account is active or as needed to provide you services. We will retain and use your information as necessary to comply with our legal obligations, resolve disputes, and enforce our agreements.

7) SECURITY: Novum maintains a high level of security, particularly in relation to data. Computer equipment, networks, programs, data and documentation are maintained to a high standard, and precautions are in place to protect personal information in its possession from loss, misuse, unauthorized access, disclosure, alteration, and/or destruction. No method of transmission over the Internet, or method of electronic storage, is 100% secure, however. Therefore, while we strive to use commercially acceptable means to protect your personal information, we cannot guarantee its absolute security.

8) ENFORCEMENT: Novum will ensure adherence to this Policy by ensuring (a) readily available and affordable independent recourse mechanisms exist so that each individual's complaints and disputes can be investigated and resolved; (b) procedures for verifying that the commitments companies make to adhere to stated principles have been implemented; and (c) obligations to remedy problems arising out of a failure to comply with the principles exist. Sanctions must be sufficiently rigorous to ensure compliance by the organization.

DISPUTE RESOLUTION

Any questions or concerns regarding the use or disclosure of personal information should be directed to the Novum Participant Advocate. Novum will investigate and attempt to resolve complaints and disputes regarding the use and disclosure of personal information in accordance with the principles contained in this Policy. You may also contact us at privacy@novumprs.com. In addition, see Privacy Principles above for disputes regarding the Safe Harbor Privacy Framework.

TRAINING

Novum has provided its employees with appropriate training to ensure that all individuals who process personal information are fully aware of their responsibility with respect to data protection.

LIMITATION ON APPLICATION OF PRINCIPLES

Adherence by Novum to this policy may be limited (a) to the extent required to respond to a legal or ethical obligation; and (b) to the extent expressly permitted by an applicable law, rule or regulation.

INTERNET PRIVACY/LINKS TO THIRD PARTY WEB SITES

Novum sees the Internet and other advanced electronic technology as valuable tools for communicating and interacting with others. Novum recognizes the importance of maintaining the privacy of information collected online. Some of our Web pages may contain links to Web sites outside the Novum organization. Linked Web sites are not under the control of or endorsed by Novum. This Policy does not apply to linked Web sites outside the Novum organization.

Our Web site includes Social Media Features, such as the Facebook ‘Like’ button [and Widgets, such as the ‘Share this’ button or interactive mini-programs that run on our site]. These Features may collect your IP address, which page you are visiting on our site, and may set a cookie to enable the Feature to function properly. Social Media Features and Widgets are either hosted by a third party or hosted directly on our Site. Your interactions with these Features are governed by the privacy policy of the company providing it.

TRACKING TECHNOLOGIES

Cookies are information that your web browser places on your computer when you visit a website. Novum is able to access only the cookies that it sets on your computer, and we are only able to determine things like the type of computer operating system and browser that you and other visitors are using. Novum collects this information in the aggregate in order to improve access to our content based on our visitors' browsers and operating system types to make our content available to as many users as possible. You can, of course, disable cookies on your computer by indicating this in the preferences or option menu of your browser. Log data collected on web servers supplies us with aggregate information about the number of visits to different pages of our site and how you found our site, such as through search engines or other websites. We use this information only for improving our site.

Novum uses this information, which does not identify individual users, to analyze trends, to administer the site, to track users’ movements around the site and to gather demographic information about our user base as a whole. We do not link this automatically-collected data to personal information.

Some of our business partners (e.g., tracking utility company) use cookies and Web beacons on our site. Novum has no access to, or control over these third-party tracking utilities.

PRIVACY POLICY CHANGES

Novum reserves the right to change, modify or amend this Policy at anytime. If we make material changes to this policy, we will notify you here, by email, or by means of a notice on our home page prior to the change becoming effective. If you have questions regarding this privacy policy, please send your inquiries to: privacy@novumprs.com.